FDA.reportPublic FDA data

NDC 70518-3868-01 - Phenazopyridine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70518-3868
Requested NDC
70518-3868-01
Package NDCs from labels
70518-3868-0, 70518-3868-1, 70518-3868-2, 70518-3868-3, 70518-3868-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP Rx OnlyREMEDYREPACK INC.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3868-0Phenazopyridine Hydrochloride9 in 1 BOTTLE, PLASTICTABLET99
70518-3868-1Phenazopyridine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET219
70518-3868-2Phenazopyridine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET69
70518-3868-3Phenazopyridine Hydrochloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3868PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [REMEDYREPACK INC.]7Current NDC, 4 package rows20250309_82dc87bb-ba27-4b86-9bc9-18492975ac9f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.548edf26-c81e-f982-e063-6394a90af9da2026-06-18Warnings, Adverse reactionsExact identifier
rxcui: 1094107
unii: 0EWG668W17
Phenazopyridine HydrochloridePHENAZOPYRIDINEREMEDYREPACK INC.82dc87bb-ba27-4b86-9bc9-18492975ac9f2026-06-10Adverse reactionsExact identifier
ndc (package): 70518-3868-3
ndc (package): 70518-3868-2
ndc (package): 70518-3868-1
ndc (package): 70518-3868-0
ndc (product): 70518-3868
ndc11 (package): 70518386801
rxcui: 1094104
spl id: 53e5fcb2-f144-3739-e063-6394a90a5da0
spl set id: 82dc87bb-ba27-4b86-9bc9-18492975ac9f
unii: 0EWG668W17
Preferred Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0fa8638c-e3e0-4bbf-9101-842e5d8736d62026-06-04WarningsExact identifier
unii: 0EWG668W17
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Phenazopyridine HydrochloridePHENAZOPYRIDINE HYDROCHLORIDEGPT Pharmaceuticals Private Limited7332cbf1-ceda-415b-b4d5-a100057a7d012026-05-12WarningsExact identifier
unii: 0EWG668W17
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
UTI PAIN RELIEFPHENAZOPYRIDINE HYDROCHLORIDECadence Health7fa8e314-025c-46c2-b97a-91c4f385e5652026-04-06WarningsExact identifier
unii: 0EWG668W17
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDEYYBA CORPf2d9f6aa-081e-4723-9417-5191b31d29522026-04-01WarningsExact identifier
unii: 0EWG668W17
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.